Kornimate/medical-research-clean huggingface dataset:
lumax dx / linox dx evaluation

Conditions: Cardiac Disease

Summary: the objective of this study is to investigate the safety and efficacy of the lumax dx / linox dx system. no hypothesis has been defined.


Eligibility criteria:
inclusion criteria: * patient meets the indication for icd therapy * lvef ≥ 30% * patient's compliance with protocol * signed patient informed consent form exclusion criteria: * patient meets one contraindication for icd therapy * permanent atrial tachyarrhythmia * age \< 18 years * cardiac surgery planned within the next 6 months * life expectancy of less than 6 months * limited contractual capability * participating in another clinical study of an investigational cardiac drug or device

Keywords: cardiac disease (icd indication)
ivabradine versus beta-blockers in the treatment of inappropriate sinus tachycardia

Conditions: Inappropriate Sinus Tachycardia

Summary: the aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia.

inappropriate sinus tachycardia (ist) is a non-paroxysmal arrhythmia, characterized by a persistently high sinus heart rate (hr) and/or an exaggerated hr response to minimal exertion, and can be responsible for palpitations, asthenia, chest pain, dizziness and syncope, which can be highly invalidating. conventional treatment of ist, targeted to symptoms control, mainly consists on β-blockers. however, these drugs are often insufficient or not well tolerated because of side effects (mostly hypotension) that usually limit the administered dose. ivabradine, a sinus rate lowering agent currently employed in europe in the treatment of stable angina and chronic heart failure, has recently been demonstrated to be effective and safe in the treatment of ist by a few case reports and clinical trials. a randomized clinical trial comparing ivabradine to β-blockers has not be performed yet.

Eligibility criteria:
inclusion criteria: * inappropriate sinus tachycardia (hr \>100 bpm at rest ecg and/or medium holter ecg hr \>90 bpm) * age \> 18 years; exclusion criteria: * secondary causes of sinus tachycardia; * structural heart diseases, * postural orthostatic tachycardia syndrome; * sinus nodal reentrant tachycardia; * contraindications to beta-blockers; * administration of beta-blockers, non-di-hydropiridinic calcium channels antagonists, class i and iii anti-arrhythmic drugs or digitalis at the time of enrollment; * age \< 18 years; * inability of giving informed consent;

Keywords: inappropriate sinus tachycardia ivabradine beta blockers
perioperative cognitive trajectories in deferred surgery (cotele-surge)

Conditions: Postoperative Cognitive Dysfunction; Depressive Symptoms; Postoperative Pain

Summary: cognition is the way people use their brains to think, understand, remember and make decisions. cognitive changes are often seen even up to 1 year after surgery. whether these changes are more than what is expected for someone's age and morbidities is still uncertain. due to the covid-19 emergency, many elective surgeries have been delayed, which is stressful for patients, but also represents an opportunity of understanding better how surgery can impact cognitive abilities. the purpose of this study is to explore if and how cognitive performance changes over time for patients aged 65 years or older, whose surgery has been postponed. due to the covid-19 emergency, following and assessing the cognitive performance of these patients over time before and after surgery. in particular, in this study, the participant's cognitive performance will be assessed periodically with a computer-based instrument for cognitive testing, self-administered at home, in which tests are based on playing cards.

the primary objectives of the project are to describe perioperative cognitive trajectories of older patients whose elective noncardiac surgery has been deferred because of the covid-19 emergency, and explore the intra-individual changes in these trajectories from before to after surgery, through periodic remote self-administered cognitive testing. secondarily, in the same patients, the investigators will also describe the perioperative trajectories in depressive symptoms and pain, and study their correlation with the trajectories in cognitive performance. the study will be conducted remotely and virtually. the investigators will have an initial videoconference with the participant (and a support person if necessary) to explain the computerized cognitive test battery (i.e. the cogstate brief battery, cbb), and train on self-administration through a user-specific link. at each due assessment, the research team will call the participant to remind to complete the cbb; and to assess depressive symptoms, pain, and collect data on intercurrent clinical events (i.e. medication changes, hospitalization, ed or urgent care visits).

Eligibility criteria:
inclusion criteria: 1. age 65 years or greater; 2. patient scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery; 3. surgery deferred, with a known or probable surgery date in ≥6 weeks; 4. informed consent provided. exclusion criteria: 1. patient undergoing cardiac surgery or cranial neurosurgery; 2. known history of dementia; 3. unavailability of tablet or computer with an internet connection for remote assessment; 4. patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints; 5. patient unable to understand spoken or written english; 6. surgery delayed for an intercurrent clinical event

Keywords: older patients non-cardiac surgery cognitive trajectories
arrhythmia prediction trial

Conditions: Myocardial Infarction; Dilated Cardiomyopathy; Heart Failure

Summary: patients with ischaemic and dilated cardiomyopathy, face an increased risk for arrhythmic sudden cardiac death. the purpose of this study is to estimate the performance of modern non-invasive indices and the performance of programmed ventricular stimulation in sudden cardiac death prediction.

sudden cardiac death (scd) threatens survival of coronary artery disease and dilated cardiomyopathy patients with heart failure. discovering efficient scd risk stratification markers is of high importance. in this study, heart failure patients will be risk stratified with indices from the myocardial substrate (qrs, fragmented qrs, late potentials, lvef), indices from the repolarization status (qt duration, qt rate corrected , qt dispersion, qt/rr, t wave amplitude variability, t wave alternans, qt variability index), indices from the autonomic nervous system function \[ heart rate variability, heart rate turbulence, deceleration capacity (dc) , dc sign of fraction, beat to beat dc, non linear indices of heart rate dynamics\], the non sustained ventricular tachycardia and ventricular extrasystolic activity and the circadian properties of heart rate observed during ambulatory monitoring. furthermore programmed ventricular stimulation will be used. high resolution 30 min ecg recordings will performed for further indices research and development. all the arrhythmic risk stratifiers will be analysed and their performance for sudden cardiac death prediction and for total mortality will be estimated according the follow up.

Eligibility criteria:
inclusion criteria: * myocardial infarction * dilated cardiomyopathy * sinus rhythm exclusion criteria: * malignant diseases seriously affecting the survival * conditions/diseases affecting the autonomic nervous system's function * dementia * alcoholism * psychiatric diseases * addiction

Keywords: arrhythmic sudden cardiac death heart failure risk stratification autonomic nervous system heart rate repolarization
active cycle of breathing techniques with and without acapella in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease refers to a group of progressive lung diseases the block air flow and make it difficult to breath. it is potentially fatal and fourth leading cause of death in the world. the symptoms of this condition include shortness of breath, frequent coughing, fatigued and tightness in the chest. due to the secretions in the lungs sometime patients will have great difficulty catching the breath after walking or exercise. patient will also feel breathless just sitting or relaxing. active cycle of breathing technique can be used to mobilize and clear secretions. it will improve their stamina and reduce the episodes of breathlessness, help to remove the secretions from the lungs and feel better overall. acapella is a small hand held device which help to loosen and clear secretions from the chest it has both resistive and vibratory features. a randomized control trial will be conducted at gosha e shifa hospital and general hospital lahore through convenience sampling technique on 42 patients which will be allocated through simple random sampling through sealed opaque enveloped into group a and group b. group a will be treated with active cycle of breathing exercises/techniques and group b will be treated with acapella device with active cycle of breathing exercise .outcome measure will be conducted through modified dyspnea scale, acapella device usage and questionnaire after 4 weeks and also perform pulmonary function test .data will be analyzed using spss software version 21. after assessing normality of data by shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. acapella device uses and active cycle of breathing technique will be applied for comparing their effect in patients of copd.


Eligibility criteria:
inclusion criteria: * both men and women age between 35-50 years. * having smoking history .(1) * dyspnea mrc scale grade 2 and grade 3.(20) * gold standard copd grade 2 exclusion criteria: * any kind of infective pulmonary condition . * restrictive lung disease.(20) * pregnancy. * any severe heart disease

Keywords: copd acbts acapella, breathlessness fatigue
11c-acetate/18fluorodeoxyglucose-fdg pet/ct and cardiac mri in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: this study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.

we will measure right ventricular metabolic and structural changes using serial 11c-acetate and 18f-fdg pet/ct and cardiac mri as response to treatment with ranolazine. subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). this is a companion imaging trial for patients who are eligible for the treatment trial entitled "a randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". subjects must enroll in companion treatment protocol to qualify for the imaging protocol. the cardiac mri portion of the study continued, but the pet portion of the study was discontinued due to funding. the treatment protocol is registered under: nct01839110. due to funding issues, the completed study was registered under nct02829034.

Eligibility criteria:
inclusion criteria: participation in the companion treatment protocol "a randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction" exclusion criteria: * pregnancy or lactation: women of childbearing potential must have a negative urine or blood pregnancy test on the day of the pet/ct scan. * severe anxiety or claustrophobia prohibiting completion of imaging * inability to tolerate imaging procedures (1 hour mri, 30 min and 15 min pet) * implantable cardioverter-defibrillator, pacemaker, hazardous metallic implants or any other contraindication to mri. * uncontrolled diabetes mellitus with fasting glucose \> 150 mg/dl

Keywords: pulmonary hypertension right ventricular function 11c acetate fdg ranolazine
phase 1 study of ace-232 to treat patients with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer (Adenocarcinoma); mCRPC (Metastatic Castration-resistant Prostate Cancer)

Summary: this is an open label, phase i, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mcrpc).

the study consists of two parts, phase 1a dose escalation and phase 1b dose optimization. phase 1a aims to assess the safety, tolerability, pharmacokinetic (pk) profile, and changes in pharmacodynamic (pd) markers in patients treated with ace-232, and to determine the maximum tolerated dose (mtd), if applicable. in phase 1b, patients with ar gene alterations will be treated at two different dose levels to establish the recommended phase 2 dose (rp2d).

Eligibility criteria:
inclusion criteria: * provide written informed consent * metastatic castration-resistant prostate cancer with ongoing androgen - deprivation therapy (adt) or have bilateral orchiectomy * difficult to treat or intolerant to standard treatment (post at least 1 line of nha and taxane-based chemo in mhspc or mcrpc), suitable for investigational treatment; * has eastern cooperative oncology group (ecog) performance status of 0 or 1 * has a life expectancy of at least 6 months * adequate organ function and bone marrow function exclusion criteria: * receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period; * concomitant use of medications or herbal supplements known to be moderate to strong cyp3a4 inhibitors/inducers, or p-gp inhibitors, known to prolong the qt interval. * any previous treatment-related toxicities have not recovered. * spinal cord compression or known brain metastases or leptomeningeal carcinomatosis. * severe cardiovascular disorders. * known gastrointestinal (gi) disorder or gi procedure * history of gastric and duodenal perforation. * history of pituitary dysfunction. * poorly controlled diabetes mellitus. * active or uncontrolled autoimmune disease * active infections, or a known history of hiv infection, or a known active hepatitis b or c, or a known active tuberculosis. * other malignancies requiring treatment within 3 years prior to the first dose of study drug * known allergy or hypersensitivity to any of the excipients of ace-232. * has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.

Keywords: ace-232 castration-resistant prostate cancer crpc hormone antagonists hormone substitutes antineoplastic agents prostatic neoplasms castration-resistant prostate cancer cyp11a1
enhanced community-based asthma monitoring through novel technology

Conditions: Asthma in Children

Summary: the goal of this pilot interventional study is to learn about the implementation of a home monitoring program (using remote study visits and lung function testing) in children with asthma. the main questions to answer are: 1. do participants find the program to be feasible, acceptable and accessible? 2. what factors are associated with completion of the program? 3. does the program have an effect on asthma control and daytime sleepiness?

the primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically underserved children with persistent asthma in delaware and to determine its feasibility, acceptability, and accessibility. additionally, the proposed study aims to explore patient and family demographic characteristics and social factors associated with successful completion of the program and to explore the preliminary effect of the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime functioning.

Eligibility criteria:
inclusion criteria: * followed by a primary care practice meeting hrsa rural or medically underserved designation status * diagnosis of persistent asthma: on at least 1 controller/ preventative medication for asthma * ability to follow directions and perform study measures, including in-office spirometry at initial visit * access to mobile device with internet connectivity to connect to telehealth visit and mobile spirometer application exclusion criteria: * significant cardiopulmonary disease other than asthma (examples: cystic fibrosis, complex congenital heart disease) * non-english speaking

Keywords: asthma spirometry telehealth
phase 2 study of epi-743 in children with pearson syndrome

Conditions: Pearson Syndrome

Summary: treatment of pediatric subjects with pearson syndrome

if effective, treatment with epi-743 should result in a significant reduction in occurrence of sepsis, metabolic crisis, hepatic failure and transfusion dependence.

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of pearson syndrome * age less than 18 * availability of medical history for 12 months prior to enrollment * abstention from use of coq10, vitamin e, lipoic acid and idebenone 14 days prior to treatment with epi-743 exclusion criteria: * allergy to epi-743, sesame oil or vitamin e * clinical history of bleeding/ abnormal pt/ptt * concurrent inborn errors of metabolism * use of anticoagulant medications * participation in any interventional study within 30 days of treatment * use of erythropoietin 30 days prior to trial enrollment

Keywords: pearson epi743 epi-743 vincerinone mitochondrial disorder mitochondrial disease
diuretic response in advanced heart failure: bolus intermittent vs continuous infusion

Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Summary: loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. however, these patients often develop diuretic-resistance or even diuretic-refractoriness. in order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, k+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. at the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. the aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute heart failure.


Eligibility criteria:
inclusion criteria: * advanced heart failure * wet ≥ 12 * systolic blood pressure ≤ 110 mmhg * serum sodium ≤ 135 meq/l * left systolic ventricular insufficiency (fe \< 35%) note for at least 6 months * class nyha iii-iv despite medical treatment maximal exclusion criteria: * acute coronary syndrome * shock cardiogenic * chronic renal failure stage v
evaluation of a health monitoring platform for elderly in home care context

Conditions: Aging; Frailty

Summary: this study aims at, as a primary objective, studying acceptability of elderly about a health monitoring platform for home support and home care. the secondary objective consists in studying the correlation of different health data evolution and the frailty trajectory of the subject.


Eligibility criteria:
inclusion criteria: * age ≥ 80 years old * living at home or in senior residence * evaluated as being robust according to the fried's frailty test (0 met criteria) * affiliated or beneficiary of a social protection scheme * having given written consent exclusion criteria: * hospitalization during the month preceding the first visit * subject suffering from cognitive disorders preventing proper use of the device * subject being unable to give by himself / herself his / her consent to participate in the trial * person subject to legal protection (safeguard of justice, trusteeship, guardianship, persons deprived of liberty)

Keywords: health monitoring frailty home care home support
the effect of calcium supplementation on insulin resistance and 24h blood pressure

Conditions: Hypertension; Diabetes; Insulin Resistance

Summary: increased levels of intracellular calcium are thought to diminish maximal cellular response to insulin and induce insulin resistance. also, both hypertension and diabetes are thought to be conditions of altered intracellular ionic state. the aim of the present study is to investigate the possible effect of oral calcium supplementation on intracellular ions, insulin sensitivity, 24-h blood pressure and sodium/hydrogen exchanger activity in patients with type 2 diabetes and essential hypertension.


Eligibility criteria:
inclusion criteria: * patients with hypertension, diabetes and the metabolic syndrome (according to the definition of the national cholesterol education program, adult panel iii (ncep, atp iii). * signed the concent form exclusion criteria: * secondary hypertension * stage ii or iii hypertension * history of renal disease * sleep apnea * acute or chronic inflammation * history of coronary artery disease * heart failure stage iii or iv according to the new york heart association * active liver disease * history of malignancy * parathyroidism * history of kidney stones * calcium supplement ingestion * drugs that alter insulin resistance * treatment with insulin * alcohol abuse or other conditions with poor prognosis * treatment with non-inflammatory steroid agents, corticosteroids, or any other treatment that affects blood pressure

Keywords: calcium supplementation intracellular ions sodium/hydrogen exchange activity